• GEN2 was studied in patients with hepatocellular carcinoma or advanced solid tumors metastatic to the liver and was well-tolerated at all dose levels administered
• 21% of patients remained on study for >6 months, with half at the highest administered doses and the longest up to 21 months
• A Maximum Tolerated Dose (MTD) was not defined in this study
• A second Phase 1 study, in the US, exploring a different dosing schedule is underway; once a recommended dose in this study is defined, 3 expansion cohorts will be initiated

Pasadena, CA, November 08, 2024 (Notified GlobalNewswire) – GenVivo, Inc. (GVO) a private, clinical stage biopharmaceutical company with breakthrough “off-the-shelf” gene vector immunotherapies to treat cancer, announces the presentation of GEN2 Phase 1 clinical trial results in adult patients with hepatocellular carcinoma or tumors metastatic to the liver (NCT04313868), at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 8-10, in Houston, TX.

GEN2, a non-replicating mRNA vector, delivers two payload genes that provide dual-mechanisms of action: an enhanced prodrug-activated enzyme (HSV-eTK) and an immunostimulatory cytokine (GM-CSF). After valganciclovir administration, GEN2 triggers the local release of tumor-specific antigens (including neoantigens) to stimulate an immune response.  This novel therapy enables faster treatment, as it does not require tumor biopsies or tumor-specific genomic sequencing to identify patient-specific neoantigens prior to commencing therapy.

GEN2 was evaluated intravenously (IV) in combination with valganciclovir (VGCV) in 48 patients in this dose-escalation Phase 1 trial.  GEN2 was administered on Days 1, 2, and 3 with VGCV on days 8 to 12 on a three- week cycle.  GEN2 demonstrated tolerability and minimal toxicity, with no dose-dependent Treatment Emergent Adverse Events (TEAEs).  Linear exposure was observed across the 1000-fold dose range.  Twenty-one percent of patients remained on therapy for longer than 6 months with the longest up to 21 months.  A toxicity-defined maximum tolerated dose (MTD) has not been identified.

A second Phase 1 trial, initiated in the US earlier this year under protocol NCT06391918, will identify the Recommended Phase 2 Dose (RP2D) on a different IV schedule and expand into additional tumor types. This trial includes a variety of exploratory objectives including validation of receptor binding, pre- and post- tumor biopsy analyses, cytokine assessment, immunophenotyping and analysis of presence or absence of neutralizing antibodies to optimize the dosing schedule.  Once the RP2D has been defined, expansion cohorts will enroll patients with hepatocellular carcinoma (HCC), hormone receptor positive breast cancer and skin cancers.  An additional cohort of patients (also with skin cancers) will investigate intratumoral (IT) dosing, with the goal of obtaining paired biopsies and tissue correlative studies.

GEN2’s IV administration represents a major advancement over alternative therapies limited by IT or Intralesional (IL) approaches, as the use of local administration is usually restricted to readily accessible tumors.  While clinical trials of oncolytic viruses or replication-deficient vectors have demonstrated encouraging results in skin, bladder, prostate, pancreatic, and lung cancers (sometimes showing effects in both injected and non-injected tumors), there are practical limitations to IT or IL administration.  By contrast, GEN2’s IV administration allows for the treatment of advanced disease with malignancies that have spread widely throughout the body.

Presentation
Poster 1

• Abstract Title: “A phase 1 clinical trial of GEN2, a personalizing immunotherapy gene vector product, in combination with valganciclovir in adult patients with hepatocellular carcinoma or tumors metastatic to liver”
• Session Date and Time for Poster Presentation: Friday, November 8, 2024, from 9:00 AM to 7:00 PM CT, Poster Hall
• Abstract Number: 609
• Presenter: Alison L. Hannah, M.D. Chief Medical Officer, GenVivo, Inc.

 About GenVivo
GenVivo (GVO) is a private, vertically integrated biotechnology company founded to develop novel gene delivery and immune stimulation therapies, which activate the patient’s immune system to treat cancers.  GenVivo is committed to developing and manufacturing products that are rapidly deployed, and easily administered, with the goal of increasing cancer patient survival and improving quality of life.  GEN2, GVO’s first clinical candidate, is currently in a Phase 1 clinical trial in the US (NCT06391918).

For more information about GenVivo, visit https://genvivoinc.com/

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